A SOP shall be written after thorough understanding of the operating procedures. The author of the SOP shall have adequate knowledge, training and experience in the related areas of operation. Wherever necessary, some illustrations, drawings, flow charts or exhibits may be incorporated in the SOP, to provide better clarity and understanding.

Wherever abbreviations are used, these shall be elaborated in point no. 5.0 “Abbreviations & Definitions”.

Language of SOP

The language used in SOP shall be clear, instructive, sequential, unambiguous

and English language shall be used.

Where required, for operational purpose, if any SOP is required to be translated in vernacular language, the same shall be done by the initiator department by preparing draft of SOP. Once the concerned SOP is finalized by QA using same form (form No. SOP/QA-001/F01) and shall be finally approved by QA along with its main SOP in English language. QA shall maintain the distribution and retrieval record of this SOP separately as per SOP No. (————) “Titled-Document and Data Control”.

SOP no. of this local translated SOP shall remain same as English language SOP.

If there is a revision and / or change in the original SOP, the SOP in vernacular language shall also be revised for the desired changes.

Initiation of new SOP

For new SOP, Concerned Department personnel shall prepare the draft of SOP on format of SOP (as per format no. X/QA-001/F01) and “DRAFT” shall be written in diagonal using application watermark as shown below:

After completion of draft the user shall send it to the Department Head for review.

Department Head shall review the draft SOP, put the remarks or suggestion if any and forward it to QA Deptt.

QA personnel shall review the draft copy of SOP, write the comment if any and send it to QA Head for final approval.

QA Head or his/her designee shall review the draft copy of SOP and if suggested then necessary corrections shall be done by concerned department personnel.

After getting satisfactory correction and changes, QA Head or his/her designee shall approve the draft of SOP by making his initial.

After approval of draft, corrected soft copy of SOP shall be submitted by the concerned department to QA, concerned dept. shall delete the soft copy of respective SOP from their computer after handover it to QA.

QA personnel shall take the printouts of SOP in black ink on A4 size white paper (on one side of the paper only).

In case of the rejection of the SOP draft by QA head or his/her designee the same shall be maintain in documentation cell by QA personnel.

SOP Numbering system

Each SOP shall have a unique numbering system. Once number is allocated to any SOP the same number shall not repeated any SOP. Description for SOP numbering system is as follows:

Numbering system

Each SOP number consist eight alphanumeric character. For example first SOP prepared in QA department shall be numbered as X/QA-001.

The first alpha character indicates the location code where “X” indicates plant location.

For the department’s 3rd and 4th alpha characters indicates department code other than annexure-II. Department code mentioned in Annexure-III.

The fifth character shall be a ‘-’ (dash).

The sixth, seventh & eighth characters are numbers, which shall denote serial number of the SOP. The first SOP of any department shall be 001. The subsequent serial numbers shall be 002, 003, and so on.

g. X/QA-001.

Revision number of the next version of SOP shall be defined as per the issue number of the previous version of SOP.

Formatting of SOP

All SOPs shall have a standard common format for page layout as per annexure I.

Orientation of page shall be portrait. Landscape orientation shall also be used in annexures

Paper size shall be A-4 with width of 8.27 inch and height of 11.69 inch.

Margins setting on word file shall be as follows:

Top margin shall be 0.8 inch (0.8”)

Bottom margin shall be 0.6 inch (0.6”)

Left margins shall be 0.6 inch (0.6”)

Right margin shall be 0.6 inch (0.6”) as described below:

Page Layout from edge shall be header 1.0” and Footer 0.4”.

Page border’s line width shall be 1 point (1pt) as appears in this SOP.

Line spacing between the lines shall be as follows:

Before: 0 pt

After: 0 pt

Line Spacing: Single

All the points in the SOP shall be numbered sequentially. Similarly the sub-paragraphs of each point shall also be numbered sequentially, with an incremental number derived from the heading number. A outline system of numbering shall be followed as follows: First level shall be 1.0, 2.0, and 3.0 …….so on, Second level shall be 1.1, 1.2, 1.3……..so on, this shall continue up to fifth level and fifth level shall be 1.1.1.1.1, and after this level sub-numbering can be marked as ‘a’, ‘b’ and so on or ‘i’, ‘ii’ and so on. This sequence shall be start from the heading of responsibility.

In case where numbering of sub-paragraphs are not necessary and listing is essential, bullets or other suitable identification marks may be used to illustrate the same.

Contents of SOP

All contents of SOP shall be written by using “Times New Roman” font.

SOP content shall be divided into three parts:

Contents of Header

Contents of SOP Body

Contents of Footer

Contents of Header: contents of header is as follows:

Header shall start from the top where name of SOP initiator department shall write at the top right side with regular & bold letter in font size 12. Below this a header table shall place.

First column of this table shall have company Logo and in second column name of the company in font 14 with caps and bold letter shall be mentioned.

All the contents of header table shall remain same for all SOPs except the ‘Title’ and content for ‘SOP No.,’ ‘Revision No.’ ‘Supersedes’ & ‘Page no.’.

Description of heeder content is as follows:

Title: Subject of the SOP as per SOP no. shall be write

SOP no.: SOP no. shall be written as described in point no. 6.8

Revision No.: Revision no. shall be denoted in two numeric characters. New SOP shall carry Revision No. ‘00’ and the subsequent revisions shall be denoted by 01, 02, 03 and so on. (To be typed in regular font with font size 11).

Supersedes: Superseded number of the SOP shall be given in this column. For example, SOP/QA-001 (the first SOP of QA) when prepared for the first time (first version or edition), ‘Supersedes’ column shall be filled with the word ‘None’ and when the same is revised for the first time, ‘Supersedes’ shall be given as ‘SOP/QA-001, Rev.00’ and the ‘Revision No.’ for this SOP shall be filled as ‘01’.

‘Page No.’: Page no. shall be numbered in page X of YY & (for page 1 to 9) XX of YY format, e.g. first page of SOP of total 05 pages shall be 01 of 05. (To be typed in regular font with font size 11)

The sequence of signature in SOP header column shall be described as follows:

QA personnel shall review the SOP and write their name, designation and sign with date by hand, in ‘Checked by’

First Department Head/designee and Head or Incharge, QA or his / her designee shall also write their name, designation, sign with date in the column ‘Approved by’ hence approving the proposed SOP for implementation.

Effective Date: ‘Effective Date’ is the date when the content of SOP becomes operational for the user department(s). It shall be given by QA department after completion of training on the approved SOP, in DD/MM/YY format, by hand

Next Review Date: The ‘Next Review Date’ shall be after two years from the Effective Date of the SOP given by QA department in DD/MM/YY format, by hand. Every SOP shall be reviewed within one months of the Next Review Date, or earlier, if any amendment is required. E.g. if effective date of document is 15/01/12 then next review date for it shall be 14/01/14.

Contents of SOP Body

The content of Standard Operating Procedure (prepared in the format Annexure-1) shall contain the following headings:

Objective: as first point; an overview of the intention of preparation of Standard Operating Procedure shall be briefly mentioned under this heading. The ‘Objective’ shall always start with the word ‘To’.

Scope: as second point; describes the site(s) / location(s) / plant(s) and/ or departments to which the Standard Operating Procedure is applicable.

Responsibility: as third point; specifies designation of the personnel and name of department that shall be responsible for implementation and compliance of the Standard Operating Procedure.

Accountability: as fourth point; Deptt. Head and Head QA shall be accountable for implementation and compliance of the Standard Operating Procedure.

Abbreviations and Definitions: as fifth point; describes the meaning or explanation of term(s) which is (are) not common or having any specific meaning and expansion of abbreviation(s) used in the Standard Operating Procedure.

Procedure: as sixth point; describes the detailed procedure to be followed in simple and clear sentences. It may include the details of all operations, operational conditions and precautions to be taken, if any, etc.

Forms and Records: as seventh point; it shall enlist all specimen formats, specimen labels, flow charts or any other attachment with the SOP.

Reference : List other sop which directly affected or are relevant to the procedure.

Distribution: as eighth point; describes the distribution of the SOP to various concerned departments.

History:as ninth point; history shall contain a chronological record of significant changes / modifications in an SOP in brief, mentioned in three columns, namely: ‘Date’, ‘Revision Number’ and ‘Reason for Revision’

Note: Under ‘Date’ put date of preparation of the SOP. Under ‘Revision Number’ current revision number of the SOP shall be mentioned. Under ‘Reason for Revision’ give reasons why the SOP at previous revision number is modified. In case of new SOP write ‘New SOP’ under ‘Reason for Revision’ and in case of routine revision when the revision is not being addressed through change control procedure, write ‘Routine Revision’ under this column. (For more clarity refer ‘History’ at point no. 8.0 of this SOP)

Narrative text of each heading shall be aligned below the heading, not across the length of the heading.

Note: Method or procedure adopted for typing the text for this SOP shall be used as reference for the typing of SOPs.

Recordings, if required, as a result of implementation of an SOP shall be discussed in the relevant SOP by defining a format for the recording purpose which is termed as ‘Format’ of the SOP and shall be annexed to the SOP.

Contents of Footer

Only Format no. shall write in footer. Format no. shall be written at left side corner of the page and outside of page border

Format number shall be typed in footer as ‘Format No.: X/QA-001/F01-00’, in regular fonts in font size 10.

Training

Once the concerned SOP is approved by Head or Incharge QA, Initiator department shall conduct training of the SOP and evaluation of training thereupon, as per respective SOP on ‘Training of Personnel’.

Note: If a department prepares an SOP that involves other departments(s) in its execution, then the persons from this (these) department(s) shall also be trained.

Department Head shall ensure that training is imparted to all concerned.

After completion of training on SOP, the initiator department shall forward the SOP along with training record to QA.

QA personnel shall attached the training record with SOP and retain the records as per SOP on document control ‘SOP no. (…………)’. Preparation of Master Copy, Controlled Copy, Issuance and Distribution of SOP.

Master Copies and Controlled Copies (for distribution) of the SOPs shall be prepared by QA as described in SOP on ‘Document and Data Control’ (SOP No…….).

Issuance and distribution shall be done as per SOP ‘Document and Data Control’ (SOP No……).

Revision of SOP

Biennial review of an SOP shall be undertaken as per SOP ‘Document and Data Control’ (SOP No……) however change in any SOP shall be undertaken through SOP titled ‘Change Control’ (SOP No…..).

Storage, archive, Obsoletion of Superseded SOP

Storage, archive and Obsoletion of SOPs shall be done by QA as per SOP ‘Document and Data Control’ (SOP no.——).

Uncontrolled Copies of SOP

These are copies of SOPs made by photocopying the “MASTER COPY”, for information purposes only. They are provided, for example, to regulatory or certification authorities for their reference.

Such copies shall be made by the QA personnel (as per SOP ‘Document and Data Control’ SOP no.———-) with the knowledge and consent of the QA Head.

Master List of SOPs

QA shall maintain a master list of SOPs as per annexure III. It shall contain the list of SOP’s of all the departments.

Master list of SOPs shall approved by Head QA /designee.

The list shall be revised as and when required.

A hard copy shall be printed and signed by Head QA /designee and kept in QA records as master copy.

All the pages of SOP excluding annexures shall be signed and dated only in blue ink, using ballpoint pen.

All headings of SOP shall be in regular & bold letter and single space equivalent to font size 12 shall remain between headings to next line.

All designations and name of departments used in SOP shall start from capital letter.

If any coloured photograph is required for SOP then it can be attached as a part of annexure.

A “flow chart”, detailing about the steps involved, may be attached in the SOP.

Master copy and control copies of SOP shall not be stapled and punched.

Content of Form and Records (Annexures)

A suitable “Record format” shall be prepared for recording the control parameters and included as a part of the SOP itself.

A unique format number shall be assigned to theses format as described below:

The format of the SOP shall be numbered with fifteen characters its description is as follows:

The first eight characters of the format number shall be derived from the concerned SOP and the remaining seven characters shall be as follows

The ninth character shall be a ‘/’ (slash).

The tenth character shall always be ‘F’ which denotes ‘Format’.

The eleventh & twelfth character shall denote the Format’s Serial Number ranging format 01 to 99.

The thirteen character shall be a ‘_’ (dash).

The fortieth and fifteenth characters shall denote the Revision Number of the format. The first version of any format shall carry Revision Number ‘00’. The subsequent revisions shall have Revision Number 01, 02, so on. Example: Format number X/QA-001/F09-00 is the first version of the ninth format of first SOP of Quality Assurance.

All recording formats of SOP shall be attached with SOP as annexures.

A list of annexure(s), described in the SOP, shall be mentioned (along with annexure number in section 7.0 written as forms and records.

The annexure shall be written at the top of the page as “Annexure -I”. The numbering of the annexure should be given in roman numerals as I, II and so on.

Page no. shall be written at the bottom of page (bold number 3) but in format of SOP it shall be as define in Annexure-I.

If there is a revision in the format, which does not affect the content of the SOP, related department shall revise only annexures, not the whole SOP.

For revising annexures, initiator shall fill change control format, and take the approval of Department Head and QA Head.

Revised annexure shall prepared as master copy and then controlled copy as per SOP on Document control (SOP no. :———-) and this new master copy & controlled copy of annexure shall replace with previous copies.

A separate distribution record shall be maintained for this type of annexures.

Procedure for recall of superseded annexures and obsolescence of annexure shall be same as SOP (as per SOP on Document control, SOP no. :———-).

Other than formats any picture, list, flow chart etc. related to SOP may be attached with SOP in format of annexure.

Annexure shall also have the signature columns and stamping shall be made in all annexures.